Trial Outcomes & Findings for Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia (NCT NCT02257138)
NCT ID: NCT02257138
Last Updated: 2025-06-08
Results Overview
Maximum tolerated dose (MTD) is defined as the highest dose studied for which the incidence of dose-limiting toxicity (DLT) is less than or equal to 17% (1 out of 6).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2025-06-08
Participant Flow
Treatment Period: February 2015 to March 2021
Participant milestones
| Measure |
Ph1 (MTD) 10mg
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 15mg
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 25mg
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 50mg
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph2 Treatment (Ruxolitinib Phosphate, Decitabine)
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
3
|
3
|
16
|
|
Overall Study
COMPLETED
|
5
|
3
|
3
|
3
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Ph1 (MTD) 10mg
n=5 Participants
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 15mg
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 25mg
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 50mg
n=3 Participants
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph2 Treatment (Ruxolitinib Phosphate, Decitabine)
n=16 Participants
Patients receive 50mg ruxolitinib phosphate PO BID on days 1-28 and 20mg/m\^2 decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
|
Age, Continuous
|
84 years
n=5 Participants
|
69 years
n=7 Participants
|
77 years
n=5 Participants
|
61 years
n=4 Participants
|
69 years
n=21 Participants
|
69 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
16 participants
n=21 Participants
|
30 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksMaximum tolerated dose (MTD) is defined as the highest dose studied for which the incidence of dose-limiting toxicity (DLT) is less than or equal to 17% (1 out of 6).
Outcome measures
| Measure |
Ph1 (MTD) Treatment (Ruxolitinib Phosphate, Decitabine)
n=14 Participants
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
|---|---|
|
Maximum Tolerated Dose of Ruxolitinib Phosphate (Phase I)
|
NA Dose in Milligrams
Maximum Tolerated Dose (MTD) was not reached in this study as there were no Dose Limiting Toxicities (DLT) as defined in the Outcome Measure Description. The highest dose in the phase 1 portion of this study was 50 milligrams (mg) of ruxolitinib. The study continued to phase 2, treating all participants with 50mg ruxolitinib.
|
PRIMARY outcome
Timeframe: Up to 6 yearsComplete Response (CR) is defined as - The participant must be free of all symptoms related to leukemia and have an absolute neutrophil count \>/= 1 z 10\^9/L, no need for red blood cell transfusion, platelet count\>/+ 100 x 10\^9/L, and normal marrow differential (\</= 5 % blasts) in a normo- or hypercellular marrow. Complete Response with incomplete blood count recovery (CRi) is defined as - Same as CR but incomplete count recovery.
Outcome measures
| Measure |
Ph1 (MTD) Treatment (Ruxolitinib Phosphate, Decitabine)
n=16 Participants
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
|---|---|
|
Number of Participants With a Response (Complete Response [CR] + CR With Incomplete Blood Count Recovery) (Phase 2)
|
8 Participants
|
PRIMARY outcome
Timeframe: BaselineJAK2 mutations were assessed with the baseline Bone Marrow or Peripheral Blood.
Outcome measures
| Measure |
Ph1 (MTD) Treatment (Ruxolitinib Phosphate, Decitabine)
n=16 Participants
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
|---|---|
|
Number of Participants With Post-MPN Acute Myeloid Leukemia (AML) With JAK2 Mutations (Phase 2)
|
11 Participants
|
SECONDARY outcome
Timeframe: up to 6 yearsJAK2 mutations were assessed with the baseline Bone Marrow or Peripheral Blood. Complete Response (CR) is defined as - The participant must be free of all symptoms related to leukemia and have an absolute neutrophil count \>/= 1 z 10\^9/L, no need for red blood cell transfusion, platelet count\>/+ 100 x 10\^9/L, and normal marrow differential (\</= 5 % blasts) in a normo- or hypercellular marrow. Complete Response with incomplete blood count recovery (CRi) is defined as - Same as CR but incomplete count recovery.
Outcome measures
| Measure |
Ph1 (MTD) Treatment (Ruxolitinib Phosphate, Decitabine)
n=8 Participants
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
|---|---|
|
Number of JAK2 Positive+ and JAK2 Negative- Participants With a Response (Phase 2)
JAK 2+ Positive
|
5 Participants
|
|
Number of JAK2 Positive+ and JAK2 Negative- Participants With a Response (Phase 2)
JAK 2- negative
|
3 Participants
|
Adverse Events
Ph1 (MTD) 10mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Ph1 (MTD) 15mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Ph1 (MTD) 25mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Ph1 (MTD) 50mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Ph2 Treatment (Ruxolitinib Phosphate, Decitabine)
Serious events: 11 serious events
Other events: 11 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Ph1 (MTD) 10mg
n=5 participants at risk
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 15mg
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 25mg
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 50mg
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph2 Treatment (Ruxolitinib Phosphate, Decitabine)
n=16 participants at risk
Patients receive 50mg ruxolitinib phosphate PO BID on days 1-28 and 20mg/m\^2 decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
12.5%
2/16 • Number of events 2 • Up to 6 years
|
|
General disorders
Fatigue
|
0.00%
0/5 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
18.8%
3/16 • Number of events 5 • Up to 6 years
|
|
General disorders
Fever
|
0.00%
0/5 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
33.3%
1/3 • Number of events 2 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Infection
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
12.5%
2/16 • Number of events 2 • Up to 6 years
|
|
Nervous system disorders
Intracranial Hemorrhage
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Lung Infection
|
40.0%
2/5 • Number of events 3 • Up to 6 years
|
66.7%
2/3 • Number of events 4 • Up to 6 years
|
100.0%
3/3 • Number of events 3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
31.2%
5/16 • Number of events 9 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/5 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Skin and subcutaneous tissue disorders
Lower Extremity Rash
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Soft Tissue Infection
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
12.5%
2/16 • Number of events 2 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/5 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 2 • Up to 6 years
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
Other adverse events
| Measure |
Ph1 (MTD) 10mg
n=5 participants at risk
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 15mg
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 25mg
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph1 (MTD) 50mg
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
Ph2 Treatment (Ruxolitinib Phosphate, Decitabine)
n=16 participants at risk
Patients receive 50mg ruxolitinib phosphate PO BID on days 1-28 and 20mg/m\^2 decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Decitabine: Given IV
Laboratory Biomarker Analysis: Correlative studies
Ruxolitinib Phosphate: Given PO
|
|---|---|---|---|---|---|
|
Investigations
Alkaline Phosphatase
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/5 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Investigations
Elevated Bilirubin
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
12.5%
2/16 • Number of events 2 • Up to 6 years
|
|
General disorders
Bruising
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Cardiac Arrythmia
|
0.00%
0/5 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
25.0%
4/16 • Number of events 4 • Up to 6 years
|
|
Investigations
Elevated Creatinine
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Gastrointestinal disorders
Dry Mouth
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
General disorders
Edema Limbs
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • Up to 6 years
|
66.7%
2/3 • Number of events 2 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/5 • Up to 6 years
|
66.7%
2/3 • Number of events 2 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 2 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Gastrointestinal disorders
Hemorrhage Gastrointestial
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
General disorders
Hemorrhage Other
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Infections and infestations
Infection
|
60.0%
3/5 • Number of events 3 • Up to 6 years
|
66.7%
2/3 • Number of events 4 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
12.5%
2/16 • Number of events 2 • Up to 6 years
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
66.7%
2/3 • Number of events 2 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 3 • Up to 6 years
|
12.5%
2/16 • Number of events 2 • Up to 6 years
|
|
General disorders
Petechiae
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
20.0%
1/5 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
6.2%
1/16 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Renal/Genitourinary Other
|
0.00%
0/5 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
|
General disorders
Weight loss
|
0.00%
0/5 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
33.3%
1/3 • Number of events 1 • Up to 6 years
|
0.00%
0/3 • Up to 6 years
|
0.00%
0/16 • Up to 6 years
|
Additional Information
Dr. Farhad Ravandi-Kashani
The University of Texas MD Anderson Cancer Center
Phone: 713-745-0394
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place